Heart Failure Studies - LSU School of Medicine

Inclusion Criteria
1. Subjects with clinical diagnosis of WCHF and either
type 2 DM with or without CKD or moderate CKD
alone treated with evidence-based therapy for HF for
at least 3 months prior to emergency presentation to
hospital who meet all of the inclusion and presenting
none of the exclusion criteria will be eligible for
enrollment in the study.
2. Subjects with worsening chronic heart failure
requiring emergency presentation to hospital and
treatment with intravenous (IV) diuretics at hospital
3. Left ventricular ejection fraction (LVEF) ≤40%
4. BNP >400 pg/mL or NT-proBNP >1200 pg/mL
Exclusion Criteria
1. Acute coronary syndrome (ACS)
2. Acute infectious disease requiring IV antibiotics
3. Subjects requiring any IV vasodilating drug (e.g.
nitrates, nitroprusside), any IV natriuretic
peptide (e.g. nesiritide, carperitide) within the last
24 hours prior to randomization, or any
IV positive inotropic agents within the last 14 days
prior to dosing with study drug
Inclusion Criteria
Be receiving appropriate medical therapy for heart
failure as per ACC/AHA Guidelines for at least 3
months prior to randomization visit.
Minimum of 1 prior hospital admission within the
last 12 months for acute exacerbation of HF of at
least 1 calendar date change duration requiring IV or
invasive HF therapy. If CRT device previously
implanted, the heart failure hospitalization must be
≥ 30 days after CRT implantation. Alternatively, if
patients have not had a heart failure hospitalization
within the prior 12 months, they must have an
elevated BNP level of at least 400pg/ml or NTproBNP level of at least 1,500pg/ml within 30 days
for screening visit.
Exclusion Criteria
1. Have known coexisting, untreated, hemodynamically
severe stenotic valve lesions, vegetations,
hypertrophic cardiomyopathy with significant resting
or provoked subaortic gradient, acute myocarditis,
tamponade, or large pericardial effusion.
2. Severe Pulm. Di. producing frequent hospitalizations
for respiratory distress or requiring home oxygen
Inclusion Criteria
1. BMI < 40.
2. Symptomatic ischemic heart failure (NYHA Class III or
“ambulatory” Class IV) post MI in the LAD territory at
least 60 days prior to enrollment.
3. 15% ≤ LVEF ≤ 35% by TTE.
4. Post LV MI structural heart dysfunction represented by
LV wall motion abnormality (WMA) by
Exclusion Criteria
1. Excessive wall motion abnormalities outside the
anteroapical region.
2. Recent (within 6 months) cerebrovascular accident
(CVA) or transient ischemic attack (TIA).
3. End stage renal disease requiring chronic dialysis.
4. Obstructive Sleep Apnea (OSA): unless compliant on
CPAP therapy or successful surgery.
5. Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or
Creatinine > 2.5mg/dl.